Tower Mains Weekly Newsletter

Industry Updates

FDA recommends inclusion of Omicron BA.4/5 component for COVID-19 vaccine booster doses

Following a thorough discussion on the 28th of June, the US Food and Drug Administration’s (FDA) independent experts on the Vaccines and Related Biological Products Advisory Committee voted in favour of including a SARS-CoV-2 omicron component in COVID-19 vaccines that would be used for boosters in the US. Following the vote, the FDA advised manufacturers seeking to update their vaccines to develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component booster vaccine.

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FDA delivers progress update on 5-year veterinary stewardship plan

On 30th June, the FDA’s Center for Veterinary Medicine (CVM) released both a progress report on Phase I of its five-year action plan for Supporting Antimicrobial Stewardship in Veterinary Settings as well as a report to describe some of the data that FDA and partners collect regarding antimicrobial sales, use, and resistance in US animal agriculture and the related food chain.

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Future of UK clinical research delivery: 2022 to 2025 implementation plan

The UK Government has published its ambitious plan to create a world-leading UK clinical research environment that is more efficient, more effective, and more resilient, with research delivery embedded across the NHS England’s Research Reset programme. By delivering on this vision, it will turn the promise of innovative UK science into real improvements in disease prevention, diagnosis, and treatment. This means better healthcare and better outcomes for all patients, both in the UK and around the world.

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Global regulators identify key principles for adapting COVID-19 vaccines to tackle variants of concern

On 30th June, global regulators gathered to discuss emerging evidence to support the adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve. This took place during a workshop co-chaired by Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the FDA, and Marco Cavaleri, Head of Health Threats, and Vaccines Strategy at the European Medicines Agency (EMA), under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting focused on identifying key principles to support the adaption of COVID-19 vaccines to better match virus variants of concern and highlighted the importance of planning effectiveness studies with the adapted vaccines to determine the level of protection.

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Medical devices given exceptional use authorisations during the COVID-19 pandemic

On 1st July, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its list of manufacturers and their medical devices which have been granted an exemption by the agency. The list also includes manufacturers whose exemption expired or was cancelled.

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AstraZeneca to acquire TeneoTwo and its clinical-stage T-cell engager

On 5th July, AstraZeneca announced an agreement to acquire TeneoTwo and its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486. The acquisition of TNB-486 aims to accelerate the development of this potential new medicine for B-cell haematologic malignancies, further diversifying AstraZeneca’s multiple therapeutic mechanisms that address a wide spectrum of blood cancers.

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Issue Number: WN00068

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